Pivotal role of Pharmacovigilance Programme of India in containment of antimicrobial resistance in India

Agrawal, Vijit; Shrivastava, Tarani Prakash; Adusumilli, Pramod Kumar; Kalaiselvan, Vivekanandan; Thota, Prasad; Bhushan, Shashi

doi:10.4103/picr.picr_29_18

Cited by 17 publications

(15 citation statements)

References 7 publications

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“…Indian healthcare institutions get accreditation from bodies such as the National Accreditation Board for Hospitals and Healthcare providers (NABH). The IPC has signed a Memorandum of Understanding (MoU) with the NABH, under the Quality Council of India (QCI), to ensure for total cooperation of the hospitals on the reporting of adverse events associated with medical devices in the hospital [10].…”

Section: Accreditation Bodiesmentioning

confidence: 99%

Basics and Essentials of Medical Devices Safety Surveillance

Kalaiselven¹,

Shukla²,

Mishra³

et al. 2021

New Insights Into the Future of Pharmacoepidemiology and Drug Safety

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Medical devices are being used in healthcare facilities for diagnosis, monitoring, prevention and treatment of an array of diseases. To ensure user/patient safety associated with the medical devices being used in healthcare industry, it is of utmost importance to closely monitor the adverse events associated with the medical devices through a robust, sustainable and scaled surveillance. Materiovigilance Programme of India (MvPI) provides a reliable system to report adverse events associated with medical devices. Under MvPI, various modalities to report adverse events associated with medical devices have been developed. These modalities include an editable medical device adverse event reporting form, a toll-free helpline number and a field safety corrective action form (FSCA). FSCA form is used to notify the regulatory authority and healthcare professionals on corrective actions or recall by the manufacturer. Due to the emergence of the Coronavirus disease 2019 (COVID-19) pandemic, one-page editable form has been developed to boost the adverse event reporting of Personal Protective Equipments (PPEs). MvPI also coordinates with healthcare facilities and medical device industries across the country for reporting the medical device-related adverse events. The collected scientific data is utilized to develop regulatory policies and enhance measures to ensure the quality of medical devices. All the healthcare workers are, therefore, encouraged to report adverse events to MvPI. This chapter aims to describe the systems, procedures and modalities available for the reporting of Medical Device Adverse Events (MDAEs) in India, in order to intensify the nature of reporting and creating an environment that encourages the public to perform MDAE reporting.

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Section: Accreditation Bodiesmentioning

confidence: 99%

Basics and Essentials of Medical Devices Safety Surveillance

Kalaiselven¹,

Shukla²,

Mishra³

et al. 2021

New Insights Into the Future of Pharmacoepidemiology and Drug Safety

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“…However, close and continuous surveillance for quick detection of inappropriate use and the appearance of AMR can be difficult, especially because well-equipped laboratories with trained personnel can be scarce in certain settings [9,25]. Hence, another helpful and inexpensive strategy has been suggested for challenging scenarios: the use of pharmacovigilance (PV) data to report suspected cases of AMR, therapeutic failure, and inappropriate or off-label use of AB [26][27][28][29][30][31].…”

Section: Introductionmentioning

confidence: 99%

Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use—A Narrative Review

Sandes,

Figueras,

Lima

2024

Preprint

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The spread of antimicrobial resistance (AMR) is a global challenge. Close and continuous surveillance for quick detection of AMR can be difficult, especially in remote places. This narrative review focuses on the contributions of pharmacovigilance (PV) as an auxiliary tool for identifying and monitoring the ineffectiveness of, resistance to, and inappropriate use of antibiotics (ABs). The terms “drug ineffective,” “therapeutic failure,” “drug resistance,” “pathogen resistance,” and “multidrug resistance” were found in PV databases and dictionnaires, and denote ineffectiveness. These terms cover a range of problems that should be better investigated because they are useful in warning about possible causes of AMR. “Medication errors,” especially those related to dose and indication, are highlighted in the literature, suggesting inappropriate use of ABs. Hence, the included studies show that the terms of interest related to AMR are not only present but frequent in PV surveillance programs. This review illustrates the feasibility of using PV as a complementary tool for antimicrobial stewardship activities, especially in scenarios where other resources are scarce.

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“…The scientific community continues to propose innovative antimicrobials monitoring approaches, and some have suggested pharmacovigilance data as a potential source of information for antimicrobial stewardship programs [ 18 ]. Recent studies have underlined the potential role of Pharmacovigilance in containing rising antimicrobial resistance [ 19 , 20 ], proposing methods and tools that pharmacovigilance can offer to programs that monitor suspected resistance or cases of inappropriate use of antimicrobials. A study conducted in Russia concluded that the most frequent types of medication errors (“administration of an antibiotic in the absence of indications/wrong indication”, “incorrect dosage and regimen”, and “administration of a contraindicated drug”) associated with the use of beta-lactams were the leading risk factors of growing bacterial resistance [ 21 ].…”

Section: Introductionmentioning

confidence: 99%

Pharmacovigilance Data as a Trigger to Identify Antimicrobial Resistance and Inappropriate Use of Antibiotics: A Study Using Reports from The Netherlands Pharmacovigilance Centre

2021

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(1) Background: Antimicrobial resistance (AMR) requires urgent multidisciplinary solutions, and pharmacovigilance has the potential to strengthen current antimicrobial stewardship strategies. This study aimed to characterize AMR-relevant adverse drug reaction (ADR) reports submitted to The Netherlands Pharmacovigilance Centre; (2) Methods: We carried out a descriptive analysis of ADR reports submitted to Lareb, coded with AMR-relevant MedDRA Preferred Terms (PTs); (3) Results: Between 1998 and January 2019, 252 AMR-relevant ADR reports were submitted to Lareb. The most frequent antibiotics were tobramycin (n = 89; 35%), colistin (n = 30; 11.9%), cipro-floxacin (n = 16; 6.3%), doxycycline (n = 14; 5.5%), and aztreonam (n = 12; 4.8%). The PTs used included off label use (n = 91; 36.1%), drug ineffective (n = 71; 28.2%), product use in unapproved indication (n = 28; 11.1%), pathogen resistance (n = 14; 5.6%), and drug resistance (n = 13; 5.2%). 54% of the reports were on Watch antibiotics and 19% were involved in the Reserve group. In the Watch group, “off label use” and “product use in unapproved indication” were the most frequent PTs and the majority of reports on Reserve antibiotics were coded as “Off label”. A sharp increase in the number of reports was observed in the three consecutive years with 21 in 2013, 54 in 2014, and 83 in 2015; (4) Conclusions: In addition to existing AMR monitoring strategies, pharmacovigilance databases can serve as a source of data on suspected resistance and inappropriate use. Future research should explore how these AMR-relevant MedDRA Terms are used in resource-limited settings with less capacity to generate laboratory-confirmed resistance data.

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Pivotal role of Pharmacovigilance Programme of India in containment of antimicrobial resistance in India

Cited by 17 publications

References 7 publications

Basics and Essentials of Medical Devices Safety Surveillance

Basics and Essentials of Medical Devices Safety Surveillance

Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use—A Narrative Review

Pharmacovigilance Data as a Trigger to Identify Antimicrobial Resistance and Inappropriate Use of Antibiotics: A Study Using Reports from The Netherlands Pharmacovigilance Centre

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